A Multicenter Trial of PLA vs. Surgery for Treating PTMC
NCT ID: NCT03377829
Last Updated: 2021-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2017-12-01
2022-12-31
Brief Summary
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Detailed Description
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After a comprehensive information, patients will be consecutively assigned to Group 1 (surgery, preferentially lobectomy) or to Group 2 (percutaneous laser ablation, performed according to the attached procedure).Peri and post-operative complications, need of drug treatment, length of hospital admission and customer satisfaction will be registered.
The aims of this study are as follows: 1.To establish the rate of cure or partial ablation; 2.To compare the complication rate, time expenditure and costs of two procedures; 3.To assess changes in thyroid function and the need of substitution therapy with two procedures; 4.To assess the tolerability of the procedure, the customer satisfaction and the impact on the quality of life of the patients between conventional surgery and PLA.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Percutaneous laser ablation(PLA)
Eligible participants with PTMC will be randomly assigned to this group and undergo percutaneous laser ablation(PLA). All the process is under the detection of real-time ultrasound.After surgery, all the patients will accept contrast-enhanced ultrasound(CEUS), regular ultrasound follow-up, thyroid functional detection, fine-needle aspiration biopsy(FNAB), neck CT.Per and post-operative complications, need of drug treatment, length of hospital admission and customer satisfaction will be registered.
PLA
During the PLA, the patient is in supine position with head extended: the physician, ultrasound assistant and trained nurse work within the sterile field. Under constant ultrasound image guidance and after local anesthesia by means of 2% xylocaine infiltration, thin needles (21G) are positioned in the thyroid lesion, within safety distance from the surrounding anatomical structures. A plane-cut tip fiber optics is inserted into the PTMC through the needle. The laser at 1064 nm wavelength is turned on for 10 minutes until the pre-established energy dose is attained. There is usually no pain or very limited pain.
Surgery
Eligible participants with PTMC will be randomly assigned to this group and undergo total/subtotal thyroid surgery.
Thyroid Surgery
Patients are routinely disinfected and spread the drapes after general anesthesia. Neck skin, fat, placenta muscle are incised successively. The flap is separated to the upper edge of thyroid cartilage, neck white line is incised and anterior muscle group is separated. Then both sides thyroid lobes are exposed. Cut off the isthmus, ligature the thyroid artery, cut off the upper pole. Ligature and cut off the ipsilateral thyroid vein. Reveal and protect the ipsilateral recurrent laryngeal nerve and the parathyroid gland during the entire process. Finally patient is performed total thyroidectomy or subtotal thyroidectomy.
Interventions
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PLA
During the PLA, the patient is in supine position with head extended: the physician, ultrasound assistant and trained nurse work within the sterile field. Under constant ultrasound image guidance and after local anesthesia by means of 2% xylocaine infiltration, thin needles (21G) are positioned in the thyroid lesion, within safety distance from the surrounding anatomical structures. A plane-cut tip fiber optics is inserted into the PTMC through the needle. The laser at 1064 nm wavelength is turned on for 10 minutes until the pre-established energy dose is attained. There is usually no pain or very limited pain.
Thyroid Surgery
Patients are routinely disinfected and spread the drapes after general anesthesia. Neck skin, fat, placenta muscle are incised successively. The flap is separated to the upper edge of thyroid cartilage, neck white line is incised and anterior muscle group is separated. Then both sides thyroid lobes are exposed. Cut off the isthmus, ligature the thyroid artery, cut off the upper pole. Ligature and cut off the ipsilateral thyroid vein. Reveal and protect the ipsilateral recurrent laryngeal nerve and the parathyroid gland during the entire process. Finally patient is performed total thyroidectomy or subtotal thyroidectomy.
Eligibility Criteria
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Inclusion Criteria
* Age≥ 18 Y;
* Single nodule without thyroid capsule contact;
* There had more than 3mm distance between nodules and trachea, carotid artery, recurrent laryngeal nerve (The distance should up to 5mm after injection of isolation fluid);
* No coarse calcification or eggshell-like calcification;
* Imaging examination without local or distant metastasis;
* Without chemotherapy, radiotherapy and other related therapies;
* A complete clinical, pathological and follow-up information;
* Get informed consent signed by the patient or family member.
Exclusion Criteria
* Combined with other types of thyroid cancer or hyperthyroidism;
* Lesion contact with thyroid capsule or located in the isthmus;
* Serious coagulation dysfunction;
* Contralateral vocal cord paralysis;
* Imaging examination with local or distant metastasis;
* Active Tuberculosis and HIV-positive patients;
* Patients can not understand or follow research protocol;
* Pregnant woman.
18 Years
ALL
No
Sponsors
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WeiWei Zhan
OTHER
Responsible Party
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WeiWei Zhan
Director, Head of Ultrasound Department; Clinical Professor
Principal Investigators
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WeiWei Zhan, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital, affiliated to Medical School of Shanghai Jiaotong University
Locations
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Ultrasound Department, Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Ultrasound Department of the Third Hospital Affiliated to Zhongshan University
Guangzhou, Guangdong, China
Ultrasound Department, the Second Affiliated Hospital of Harbin Medical Univercity
Harbin, Heilongjiang, China
Ultrasound Department, the Xiangya Third Hospital of Zhongnan University
Changsha, Hunan, China
Ultrasound Department, the First Affliction Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Ultrasound Department, the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Ultrasound Department, First people's Hospital Affiliated to Medical School of Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Ultrasound Department, Ruijin Hospital Affiliated to Medical School of Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
The department of ultrasound ,second affiliated hospital of xi'an jiaotong university
Xi’an, Shanxi, China
Department of Ultrasonography, Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Department of Ultrasound Medicine, the First Hospital Affiliated to Medical School of Zhejiang University
Hangzhou, Zhejiang, China
Department of Endocrinology, Regina Apostolorum Hospital
Rome, , Italy
Diagnostic Imaging, Regina Apostolorum Hospital
Rome, , Italy
Countries
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Central Contacts
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Facility Contacts
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Guo-qing Du
Role: backup
Other Identifiers
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1001253709008902933
Identifier Type: -
Identifier Source: org_study_id
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